Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2025-12-30 @ 3:47 AM
Study NCT ID:
NCT03041168
Status:
TERMINATED
Last Update Posted:
2021-11-11
First Post:
2017-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors
Sponsor:
Thomas Jefferson University
Organization:
Study Overview
Official Title:
Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors
Status:
TERMINATED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was stopped due to suspension of funding from CVR Global.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study is evaluating a novel technology, Carotid Stenotic Scan (CSS), developed by the sponsor, CVR Global. Study Design. This is a prospective cohort study that will compare a new application of a technology, the CSS device, to reference standards for assessment of carotid disease.
Detailed Description:
The overall objectives of this study are to demonstrate that the Carotid Stenotic Scan (CSS) can accurately detect significant carotid artery stenosis.
Secondary objective is to relate changes in CSS signal to different degrees of stenosis. We obtain a "proof of concept" if the device correlates strongly with the established classification of atherosclerotic carotid disease derived various imaging modalities including magnetic resonance angiography (MRA) and computer tomographic angiography (CTA), conventional angiography, or carotid ultrasound.
Secondary objective is to relate changes in CSS signal to different degrees of stenosis. We obtain a "proof of concept" if the device correlates strongly with the established classification of atherosclerotic carotid disease derived various imaging modalities including magnetic resonance angiography (MRA) and computer tomographic angiography (CTA), conventional angiography, or carotid ultrasound.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: